Immunoglobulins, Normal Human, For Extravascular Adm.

Immunoglobulins is a prescription medicine used to treat primary immune deficiency (PI). It contains antibodies from human plasma, called immunoglobulin G (IgG), that healthy people have to fight germs (bacteria and viruses).

This medication works by temporarily providing the antibodies necessary to fight infection.

This medication comes as a liquid to be injected just under the skin (subcutaneously) using an infusion pump. It is usually given once every week or once every 2 weeks.

Common side effects include redness, swelling and itching at the injection site as well as headaches, nausea, and fatigue.

Immunoglobulins, Normal Human, For Extravascular Adm. may be found in some form under the following brand names:

• Gammagard

• Gamunex-C

• Privigen

Serious side effects have been reported. See "Precautions" section.

Side effects are generally mild and tolerable and may include:

• Redness, swelling and itching at injection site
• Headache
• Blood pressure changes 
• Nausea
• Vomiting
• Dizziness
• Fever
• Fatigue
• Chills 
• Pain in the back, joints, arms and legs

Tell your healthcare provider if any side effect is bothersome or does not go away. These are not all the possible side effects of this medication. 

You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported including:

• Anaphylaxis (a life-threatening allergic reaction)
• Serious Kidney Disease
• Pulmonary Embolism (blood clot to the lung)
• Aseptic Meningitis Syndrome (a type of brain inflammation)
• Hemolytic Anemia (a serious blood problem)
• Serious lung problems

Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Tell your doctor right away if you have any of the following symptoms. They could be signs of a rare, but serious problem.

• Decreased urination, sudden weight gain, fluid retention/swelling in your legs, and/or shortness of breath. They could be signs of a serious kidney problem called renal failure.
• Pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. These could be signs of a blood clot in your body (thrombosis). Immediately report symptoms of thrombosis.
• Severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea and vomiting. These could be signs of a type of brain inflammation called aseptic meningitis.
• Increased heart rate, fatigue, yellow skin or eyes, and dark colored urine. These could be signs of a type of blood problem called hemolytic anemia.
• Chest pains, trouble breathing, blue lips or extremities, and fever. These could be signs of a lung problem called TRALI (transfusion-related acute lung injury).
• Fever over 100°F. This could be a sign of an infection. 

Do not take this medication if you have too much proline in your blood (called "hyperprolinemia") or if you have had reactions to polysorbate 80.

Tell your doctor if you have had a serious reaction to other immune globulin medicines or if you have been told that you also have a deficiency of the immunoglobulin called IgA.

Tell your doctor if you have a history of heart or blood vessel disease or blood clots, have thick blood, or have been immobile for some time. These things may increase your risk of having a blood clot after using Hizentra. Also tell your doctor what drugs you are using, as some drugs, such as those that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot.

Medications can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication there are no specific foods you must exclude from your diet.

WARNING: THROMBOSIS

• Thrombosis may occur with immune globulin products1-3, including this medication. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
• For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.